Since the infamous Kim Kardashian Instagram post went up and the FDA issued a Warning Letter to Duchesnay, the company she was representing, a couple of things have happened. For one, Kim has issued a corrective post (i.e., ad), which outlined the safety information for Diclegis, the medication for morning sickness she is promoting. And, […]
Posts Tagged ‘drug safety’
A Facebook Post Gets Pfizer To Discuss Prescription Drug Abuse
If you visit the Gloucester Police Department’s Facebook page, you’ll notice their posts from September 16th and 18th received thousands of likes, shares, and comments. That’s for good reason. On September 16th, the department called out five pharma CEOs with the highest salaries and urged readers to contact them and ask what they’re doing […]
UCB’s EVP And CMO Opens Up About Digital Transformation
Digital transformation (DT), the concept of leveraging digital technologies to engage with constituents (e.g., customers, patients, employees, or partners) is vital in today’s world. The audience you’re targeting expects communication to be easy and information to be readily available at any time. If they can’t get what they want from you, they’ll go somewhere […]
The Troubles With Adverse Event Reporting
According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]
Why Clinical Trial Data Isn’t Enough
Life sciences organizations are in the business of developing drugs and medical devices. Hitting key milestones and moving trials to the next phase has always been a priority. Throughout this entire process, the collection and analysis of clinical and safety data is essential in taking products to subsequent stages, and ultimately getting them approved […]
What Are CAPAs And Why Are They Important?
In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you. The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following […]
Analysis Finds Reporting Delays For Serious Adverse Events
According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if […]
Detecting Adverse Events With Google? The FDA Is Interested.
Editorial Credit: Gil C / Shutterstock.com Analyzing Google searches to uncover previously unknown adverse events isn’t news, per se, but it looks like it could be gaining traction with the FDA. According to a recent Bloomberg article, the FDA’s public calendar shows that several employees from Google met with the FDA to discuss the possibility […]
Yes, Perficient Is Looking To Hire People Like You
As long as you have the experience listed in the job descriptions. But, to put it simply, if you’ve worked in the life sciences industry, you’re already ahead of the game. Check out the job openings we have on our life sciences team and apply if you’re interested. We’ll keep your application secret. Promise. […]
Accessing Previous Adverse Event Cases In Argus Safety
The last post we wrote on Argus Safety features was about the system’s autocomplete functionality. Another great feature of Oracle’s safety and pharmacovigilance system is the ability to quickly go back to an adverse event case that you previously accessed. This can be done in just a couple of clicks from the menu, saving you […]
Argus Safety 8.0 Released! Reporting And Integration Heaven
Coinciding with the Drug Information Association’s (DIA) 51st Annual Meeting in Washington, D.C. last week, Oracle announced the newest version of its drug safety and pharmacovigilance system. Argus Safety 8.0, considered a major release, offers new features and functionality to help life sciences companies comply with ever-changing global regulatory requirements. The Standard Edition of […]
A Google-Like Feature In Oracle Argus Safety
When evaluating Oracle Argus Safety for the reporting and management of adverse events or product complaints, one thing is clear to me; a company can save a tremendous amount of time by leveraging Argus’ innate functionality to assist in the tedious tasks around case entry. In the next few blog posts, we will look at several […]